ACNE DEFENSE FACE WASH- salicylic acid liquid 
Pacifica Beauty, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Acne Defense Face Wash

Active ingredient Purpose

Salicyic Acid 2.0% Acne Medication

Use

For the treatment of acne.

Warnings

For external use only. When using this product: skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.

When using this product: skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Cover the entire affected area with a thin layer and rinse thoroughly one to three times daily. Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor. If bothersome dryness or peeling occurs, reduce application to once a day or every other day. Sensitivity test for a new user. Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated above.

Inactive ingredients:

Aqua, Cocamidopropyl Betaine, Sodium C14-16 Olefin Sulfonate, Aloe Barbadensis Leaf Juice*, Glycerin, Niacinamide, Cucumis Sativus (Cucumber) Fruit Extract*, Lavandula Angustifolia (Lavender) Flower/Leaf/Stem Extract*, Chamomilla Recutita (Matricaria) Flower Extract*, Camellia Sinensis (White Tea) Leaf Extract*, Arnica Montana Flower Extract*, Salvia Officinalis (Sage) Oil, Mentha Piperita (Peppermint) Oil, Panthenol, Allantoin, Potassium Sorbate, Sodium Benzoate, Sodium PCA, Ethylhexylglycerin, Parfum**. *certified organic **our scent blend with natural and/or essential oils.

Questions or comments?

Call toll free 1-888-322-2466
Pacifica Beauty LLC Portland, Oregon

Acne Defense Face Wash Label

Acne Defense Face Wash Label

ACNE DEFENSE FACE WASH 
salicylic acid liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61197-120
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID2 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
PANTHENOL (UNII: WV9CM0O67Z)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)  
LAVENDER OIL (UNII: ZBP1YXW0H8)  
WHITE TEA (UNII: O0M3396E09)  
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
SAGE OIL (UNII: U27K0H1H2O)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
ALLANTOIN (UNII: 344S277G0Z)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
WATER (UNII: 059QF0KO0R)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CUCUMBER FRUIT OIL (UNII: R81Y52NPCT)  
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
NIACINAMIDE (UNII: 25X51I8RD4)  
CHAMOMILE FLOWER OIL (UNII: 60F80Z61A9)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61197-120-00172 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product02/08/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM00602/08/2023
Labeler - Pacifica Beauty, LLC (868275517)
Establishment
NameAddressID/FEIBusiness Operations
Sun Deep Inc.189788201manufacture(61197-120)

Revised: 2/2023
Document Id: f43590c7-84c1-6eb8-e053-2a95a90a01a7
Set id: f43590c7-84c0-6eb8-e053-2a95a90a01a7
Version: 1
Effective Time: 20230208
 
Pacifica Beauty, LLC